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Perit Dial Int 29(2): 182-190
2009
© 2009 International Society for Peritoneal Dialysis
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Clinical

LONG-TERM MODALITY-RELATED MORTALITY ANALYSIS IN INCIDENT DIALYSIS PATIENTS

Chin-Chan Lee, Chiao-Yin Sun and Mai-Szu Wu

School of Medicine, Chang Gung University, Taoyuan, Taiwan; Division of Nephrology, Chang Gung Memorial Hospital, Keelung, Taiwan

Correspondence to: M.S. Wu, Division of Nephrology, Chang Gung Memorial Hospital, 222, Mai-Chin Road, Keelung, Taiwan. maxwu1{at}adm.cgmh.org.tw


   ABSTRACT
TOP
 ABSTRACT
PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 DISCLOSURE
 REFERENCES
 

{diamondsuit} Background: The effects of the various dialysis modalities on patient survival are different, especially for diabetic patients. Hemodialysis (HD) and peritoneal dialysis (PD) are the predominant renal replacement modalities. This study analyzes modality-related mortality in long-term dialysis patients.

{diamondsuit} Methods: This prospective cohort study was conducted between May 1991 and October 2005. Incident patients that had initiated dialysis and had been on dialysis for more than 3 months were enrolled. All cause, infection related, and cardiovascular disease-related mortalities were used as end points. Patient survival was analyzed by the Cox proportional hazards model after adjusting for age, sex, diabetes, comorbidity, and time-averaged values of laboratory data to control influential covariates.

{diamondsuit} Results: In total, 1347 patients (258 on PD and 1089 on HD) were enrolled. Adjusted all cause, infection related, and cardiovascular disease-related mortality did not differ significantly between HD and PD patients. In diabetic patients, adjusted all-cause [HD vs PD: hazard ratio (HR) 0.717, 95% confidence interval (CI) 0.400 – 1.282] and infection-related mortality (HD vs PD: HR 1.341, 95% CI 0.453 – 3.969) did not differ significantly between patients on HD and patients on PD. However, adjusted cardiovascular disease-related mortality increased significantly in diabetic PD patients (HD vs PD: HR 0.375, 95% CI 0.154 – 0.913). For nondiabetic patients, adjusted all cause, infection related, and cardiovascular disease-related mortality did not differ significantly between HD and PD patients.

{diamondsuit} Conclusions: Dialysis modality had no significant impact on all-cause or infection-related mortality. More studies are needed to clarify the putative difference in cardiovascular mortality risk between diabetic patients on PD and diabetic patients on HD.

KEY WORDS: Mortality risk; cardiovascular disease; diabetes mellitus; modality; hemodialysis.

The prevalence of end-stage renal disease (ESRD) has increased markedly on a global scale during the past few years. Most ESRD patients are being maintained on renal replacement therapy (RRT); however, ESRD patients on maintenance RRT have life spans far below those of the general population (1). Diabetic ESRD patients have relatively worse outcomes (1–5). Improving the long-term outcome of these patients is still a significant problem for nephrologists.

Hemodialysis (HD) and continuous ambulatory peritoneal dialysis (PD) are the two principal modalities for maintenance dialysis. To enhance long-term prognosis, understanding the relative impact of the different modalities on long-term clinical outcome is necessary. Many studies have investigated the relative effect upon mortality of PD versus HD. However, these studies were flawed in that they had short observational periods and assessed only prevalent patients (2,4–13). In addition, these studies always utilized initial clinical data, which do not reflect the patient's clinical condition during dialysis therapy. Clinical factors following initiation of dialysis, such as malnutrition, anemia, inadequate dialysis, and hyperphosphatemia, are strongly associated with mortality risk for dialysis patients (14–17). Moreover, almost all previous studies were multicenter studies. Uncontrolled center-related bias may have contributed to the inconsistent results obtained in those studies. All these factors contribute to conflicting data in the literature.

To assess the long-term impact of dialysis modality, this study utilized a prospective cohort study in a single center. This long-term prospective cohort study assessed the survival of incident ESRD patients receiving HD versus PD by adjusting for age, sex, diabetes, comorbidity, clinical factors, and time-averaged laboratory data after initiation of dialysis at a single center.


   PATIENTS AND METHODS
TOP
 ABSTRACT
 PATIENTS AND METHODS
RESULTS
 DISCUSSION
 DISCLOSURE
 REFERENCES
 
PATIENTS
This prospective study was conducted in a cohort of incident patients receiving chronic dialysis for more than 3 months between May 1991 and October 2005 at Chang Gung Memorial Hospital, Keelung, Taiwan. Patients with malignancy, chronic obstructive pulmonary disease, decompensated liver cirrhosis, New York Heart Association functional class IV heart failure, or vegetative life were excluded. In total, 1347 patients (1089 on HD and 258 on PD) were enrolled in this cohort study. Except for those with clinical contraindications, patients chose their dialysis modality after a thorough chronic kidney disease education program designed for patients. The only absolute contraindication for PD was peritoneal adhesions due to previous abdominal surgery or inflammatory disease. Patient characteristics were age when dialysis was initiated, sex, and comorbid diabetes mellitus. Patients were classified as diabetic based on the presence of diabetes when dialysis was initiated.

STUDY END POINTS
All cause, infection related, and cardiovascular disease (CVD)-related mortalities were study end points. Cardiovascular mortality was defined as mortality caused by ischemic heart disease, congestive heart failure, cerebral stroke, or sudden death. Infection-related mortality was defined as death directly caused by an infection diagnosed by microbiological or serological studies. Death within 30 days after changing renal replacement modality was attributed to the previous modality.

CLINICAL DATA
Some clinical conditions were related to mortality. To adjust for these clinical data between patients on HD and patients on PD, this study analyzed clinical data related to mortality. Time-averaged data are considered better indicators than single point data when evaluating time-dependent longitudinal variance (18). In this study, time-averaged data represent the weighted effects during initial and later dialysis periods. This study analyzed time-averaged cardiothoracic ratio; levels of hemoglobin, serum albumin, calcium, phosphate, uric acid, intact parathyroid hormone (iPTH), cholesterol, triglyceride, and creatinine; and Kt/V and creatinine clearance rate. Serum albumin concentration was measured using the bromcresol purple method. The Kt/V for HD was measured using the Daugirdas method.

STATISTICAL ANALYSES
For normally distributed continuous variables, the two-tailed Student's unpaired t-test was employed to assess differences between means. The chi-square test was utilized to measure the association between or among categorical parameters. Variables such as age at the start of dialysis, sex, presence of diabetes mellitus; levels of hemoglobin, serum albumin, triglyceride, cholesterol, iPTH, uric acid, calcium–phosphate product, and creatinine; cardiothoracic ratio, and dialysis modality were subjected to Cox proportional hazards analysis to identify the independent mortality risk factors for all dialysis patients. To eliminate multicollinearity, calcium–phosphate product estimates were based on a model that did not include calcium and phosphate at the same time. The indices of dialysis dose (Kt/V in HD and weekly creatinine clearance and Kt/V in PD) were added to the stratified analysis of dialysis modalities separately. Backward stepwise analysis was applied to remove insignificant variables.

Actuarial survival rates for dialysis patients were analyzed by Kaplan–Meier analysis. Cox proportional hazards regression models were applied to compare survival of patients undergoing HD and PD. These models were adjusted for the effect of independent mortality risk factors identified from previous analyses, including age when dialysis was initiated, sex, hemoglobin, cholesterol, albumin, and creatinine levels, and cardiothoracic ratio. As hazard rates in diabetic and nondiabetic patients are not proportional (2), models were stratified based on the comorbidity of diabetes mellitus. Patients that received renal transplantation, changed dialysis modes, or were lost to follow-up were censored from survival analysis. When analyzing infection-related and CVD-related mortality, patients were eliminated for all causes of death other than those due to infection or CVD.

The statistical analyses utilized Stata 10.0 software (StataCorp LP, College Station, TX, USA). Continuous variables are expressed as mean ± standard deviation. A value of p < 0.05 was considered statistically significant.


   RESULTS
TOP
 ABSTRACT
 PATIENTS AND METHODS
 RESULTS
DISCUSSION
 DISCLOSURE
 REFERENCES
 
PATIENTS' CHARACTERISTICS AND CLINICAL PARAMETERS
In total, 1347 patients (1089 on HD and 258 on PD) were enrolled. Table 1 lists the causes of ESRD for patients on HD and PD. Diabetes accounted for 38.3% (516/1347) of ESRD cases. Table 2 lists patient characteristics and average values for clinical factors throughout the entire study period. Roughly 39.2% of patients were ≥65 years of age at start of dialysis (42.7% on HD and 24.4% on PD). The PD patients were younger (51.7 ± 15.5 years) than the HD patients (60.6 ± 14.4 years) (p < 0.001) when they started dialysis. Prevalence of diabetes mellitus was higher in HD patients (40.1%, 437/1089) than in PD patients (30.6%, 79/258) (p = 0.005). The PD patients had significantly higher serum cholesterol and triglyceride levels than the HD patients. The PD patients had lower serum albumin and uric acid levels than the HD patients. No significant differences existed between the two patient groups for hemoglobin, calcium, phosphate, calcium–phosphate product, iPTH, or creatinine levels (Table 2). Cardiothoracic ratios were significantly different between PD (48.3% ± 9.1%) and HD (50.3% ± 7.8%) patients (p = 0.003). We further adjusted the cardiothoracic ratios for age between PD and HD patients. Cardiothoracic ratios did not differ significantly between PD and HD patients after adjusting for age (p = 0.118) (Table 2). In nondiabetic patients, cardiothoracic ratios were not significantly different between PD (47.5% ± 8.3%) and HD (49.4% ± 7.5%) patients after adjusting for age (p = 0.413). In diabetic patients, cardiothoracic ratios were not significantly different between PD (50.2% ± 10.4%) and HD (51.8% ± 8.1%) patients after adjusting for age (p = 0.241).


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  		TABLE 1 Causes of End-Stage Renal Disease (ESRD)

 

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  		TABLE 2 Patient Characteristics and Clinical Factors

 

RISK FACTORS FOR MORTALITY
This study attempted to identify risk factors for mortality, other than dialysis modality, and adjusted for these factors during analysis of modality-related survival. Demographic characteristics, comorbidity, and laboratory factors (Table 2) were analyzed using Cox proportional hazard models (backward stepwise, probability remove: 0.1) to identify independent mortality risk factors. Table 3 presents a summary of analytical results. Age when dialysis started, male sex, comorbidity of diabetes mellitus, cardiothoracic ratio, and levels of hemoglobin and serum creatinine, cholesterol, and albumin were independent mortality risk factors for dialysis patients.


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  		TABLE 3 Independent Risk Factors for Mortality in Dialysis Patients

 

CAUSES OF MORTALITY
Table 4(A) lists the causes of mortality for dialysis patients. Infection and CVD were the leading causes of mortality for dialysis patients. Infectious disease caused 41.6% (142/341) of mortality cases in dialysis patients, causing more mortality in HD patients (44.4%, 123/277) than in PD patients (29.7%, 19/64) (p = 0.031). Cardiovascular disease caused 36.7% (125/341) of mortalities overall. The causes of mortality were not significantly different between nondiabetic patients on HD and nondiabetic patients on PD [Table 4(B)].


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  		TABLE 4 Causes of Mortality in All Patients, Nondiabetic Patients, and Diabetic Patients

 

Infectious disease was the leading cause of death in diabetic dialysis patients (43.5%, 73/168) [Table 4(C)]. Infectious disease caused more mortality in diabetic patients on HD (48.2%, 66/137) than diabetic patients on PD (22.6%, 7/31) (p = 0.009). Conversely, CVD was the leading cause of mortality for diabetic patients on PD (61.3%, 19/31) and caused significantly more mortality for diabetic patients on HD (35.0%, 48/137) (p = 0.007) [Table 4(C)].

ALL-CAUSE MORTALITY
Actuarial 5-year survival rate of all HD and PD patients was 0.68 and 0.63 respectively [Figure 1(a)]. Actuarial 5-year survival rate of nondiabetic HD and PD patients was 0.76 and 0.75 respectively [Figure 1(b)], and for diabetic HD and PD patients, 0.54 and 0.26 respectively [Figure 1(c)]. All-cause mortalities analyzed by Kaplan–Meier analysis were significantly higher for diabetic PD patients than for diabetic HD patients (log-rank: < 0.001) [Figure 1(c)].


Figure 1
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  		Figure 1 — All-cause mortality by Kaplan–Meier analysis for all patients (A), nondiabetic patients (B), and diabetic patients (C). PD = peritoneal dialysis; HD = hemodialysis.

 
All-cause mortality rates did not differ significantly between HD and PD patients after adjusting for the presence of diabetes mellitus and independent mortality risk factors [HD vs PD: hazard ratio (HR) 0.750, 95% confidence interval (CI) 0.511 – 1.099; p = 0.140]. No significant difference existed for all-cause mortality between nondiabetic HD and nondiabetic PD patients (HD vs PD: HR 0.719, 95% CI 0.423 – 1.222; p = 0.220). Adjusted all-cause mortality was not significantly different between diabetic HD and diabetic PD patients (HD vs PD: HR 0.717, 95% CI 0.400 – 1.282; p = 0.262).

We further analyzed the possible survival difference between PD and HD patients during the first 2 years on dialysis after adjusting for all risk factors. The relative risk (RR) of all-cause mortality was not different between HD and PD patients (HD vs PD: HR 1.452, 95% CI 0.802 – 2.630; p = 0.218) during the first 2 years on dialysis. The relative risk of all-cause mortality was not significantly different between diabetic HD and diabetic PD patients (HD vs PD: HR 1.073, 95% CI 0.471 – 2.443; p = 0.865), nor was it different for nondiabetic patients on HD or PD (HD vs PD: HR 2.140, 95% CI 0.823 – 5.568; p = 0.119) during the first 2 years on dialysis.

INFECTION-RELATED AND CVD-RELATED MORTALITY
Actual mortality rate due to infection was not significantly different between HD and PD patients (Figure 2).


Figure 2
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  		Figure 2 — Infection-related mortality by Kaplan–Meier analysis for all patients (A), nondiabetic patients (B), and diabetic patients (C). PD = peritoneal dialysis; HD = hemodialysis.

 
Actual mortality rate due to CVD was significantly higher in PD patients than in HD patients (log-rank 0.019) [Figure 3(a)]. In nondiabetic patients, actual mortality rate due to CVD was not significantly different between HD and PD patients (log-rank 0.964) [Figure 3(b)]. Actual mortality rate due to CVD was significantly higher for diabetic PD patients than for diabetic HD patients (log-rank < 0.001) [Figure 3(c)].


Figure 3
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  		Figure 3 — Cardiovascular disease-related mortality by Kaplan–Meier analysis for all patients (A), nondiabetic patients (B), and diabetic patients (C). PD = peritoneal dialysis; HD = hemodialysis.

 

To confirm further the difference in infectious and cardiovascular mortality between PD and HD patients, this study compared mortality risk of infectious disease and CVD between HD and PD patients by adjusting for independent mortality risk factors. The mortality risk for infectious disease remained not significantly different between HD and PD patients (HD vs PD: HR 1.168, 95% CI 0.577 – 2.363; p = 0.666). The relative risk of infection-related mortality was not different between nondiabetic HD and nondiabetic PD patients (HD vs PD: HR 0.929, 95% CI 0.353 – 2.448; p = 0.882). No significant difference in infection-related mortality risk existed between diabetic HD and diabetic PD patients after adjusting for independent risk factors (HD vs PD: HR 1.341, 95% CI 0.453 – 3.969; p = 0.596).

Cardiovascular mortality was not significantly different between PD and HD patients after adjusting for independent risk factors (HD vs PD: HR 0.583, 95% CI 0.320 – 1.062; p = 0.078). No significant difference existed for cardiovascular mortality between nondiabetic HD and nondiabetic PD patients (HD vs PD: HR 0.947, 95% CI 0.386 – 2.325; p = 0.906). However, for diabetic patients, PD patients had a significantly higher risk for cardiovascular mortality than HD patients (HD vs PD: HR 0.375, 95% CI 0.154 – 0.913; p = 0.031).

Table 5 presents the relative risks for all-cause, infection-related, and CVD-related mortality. Analytical results demonstrated that the PD modality was independently associated with increased cardiovascular mortality in diabetic patients after adjusting for all other risk factors.


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  		TABLE 5 Summary of Relative Risks of All-Cause, Infection-Related, and Cardiovascular Disease-Related Mortality (Hemodialysis Versus Peritoneal Dialysis). Relative mortality risk was adjusted by age at dialysis initiation, sex; levels of hemoglobin, and serum cholesterol, albumin, and creatinine; cardiothoracic ratio, and diabetes mellitus (in all-patient analysis).

 


   DISCUSSION
TOP
 ABSTRACT
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
DISCLOSURE
 REFERENCES
 
Diabetes mellitus is a leading cause of ESRD, especially in industrialized nations (1). A study based on the whole-country registry of Taiwan demonstrated that diabetes mellitus was the cause of ESRD in approximately 40% of incident patients (Taiwan Society of Nephrology, 2004). The present study obtained a similar finding for incident dialysis patients (38.3%, 516/1347). The rate of incident dialysis patients choosing PD as RRT is low in Taiwan compared with other countries. According to a report by the Taiwan Society of Nephrology (2004), 8.7% of incident dialysis patients choose PD as RRT in Taiwan. The major cause of this low PD rate in Taiwan is not contraindications, but patients' refusal of PD. In our center about 20% of incident dialysis patients choose PD as RRT. The PD rate in incident dialysis patients is higher in our center than the average rate of our whole country.

Although the life expectancy of patients with ESRD has improved since the introduction of dialysis, it remains far below that of the general population, and is worse for diabetic patients. In the USA, the overall 5-year survival rate for dialysis patients is ≤50% for nondiabetics and even lower for diabetics (<25%) (1). The survival rate for dialysis patients in the present study is similar. The actuarial 5-year survival rates for HD and PD patients were 0.68 and 0.63 respectively, and were worse for diabetic patients (HD: 0.54, PD: 0.26).

The impact of dialysis modality on clinical outcome is controversial. For the different dialysis techniques and mechanisms, HD and PD patients share clinical parameters; however, hypoalbuminemia and dyslipidemia are more common in PD patients (19,20). Possible inadequate total body fluid removal, which is a major concern for PD patients, may increase overall mortality risk (21). Rapid loss of residual renal function was more common in our HD patients than in our PD patients. All of these differences may increase the difficulty of studying the impact of dialysis. The present study adjusted all possible factors and examined the impact of the dialysis modality itself on clinical outcome over the long term (up to 15 years) for incident dialysis patients at a single center located in a small city where the population changes little. This study clearly demonstrated that PD is independently associated with high cardiovascular mortality in diabetic patients.

Compared with analytical results obtained by recent studies, the mortality risk for PD patients did not differ from that for HD patients when demographic and clinical (including comorbidity) characteristics were adjusted (PD vs HD: RR 1.01, 95% CI 0.99 – 1.02) in a USA Medicare study (5). The short-term CHOICE study obtained similar analytical results (PD vs HD: RR 1.35, 95% CI 0.97 – 1.87) (12); however, when baseline laboratory characteristics were adjusted, both studies revealed that PD was associated with increased mortality risk (USA Medicare: PD vs HD: RR 1.04, 95% CI 1.03 – 1.06; CHOICE: PD vs HD: RR 1.61, 95% CI 1.13 – 2.03) (5,12). The present study determined that actuarial survival did not differ between incident PD and HD patients. The relative risk of all-cause mortality did not differ between incident PD and HD patients when demographic, comorbidity, and laboratory values were adjusted for the dialysis period.

Studies comparing the effects of dialysis modalities on diabetic patients obtained conflicting results (5,12,22). The CHOICE study reported that diabetic patients on PD had a mortality risk similar to HD patients (PD vs HD: RR 1.23, 95% CI 0.79 – 1.94) (12). In the USA Medicare study, diabetic patients on PD had higher mortality risk than patients on HD (PD vs HD: RR 1.16, 95% CI 1.13 – 1.20) (5). Using time-dependent estimates of RR, the Netherlands Cooperative Study of the Adequacy of Dialysis found no difference in overall survival between PD and HD patients during the first 2 years after dialysis was initiated; however, after 2 years, HD was associated with better survival than PD (22). In this study, the mortality rate analyzed by Kaplan–Meier analysis was higher in diabetic PD patients than in diabetic HD patients. However, diabetic PD patients had survival rates similar to those of diabetic HD patients after adjusting for mortality risk factors. The discordant results of Kaplan–Meier analysis and Cox proportional model underline the importance of adjusting for risk factors in a different patient demographic distribution, such as that for dialysis patients in this study. Conversely, no difference in survival existed among nondiabetic dialysis patients.

In Western countries, CVD is a leading cause of mortality in dialysis patients (1,23). In the present study, infectious disease was the leading cause of mortality for dialysis patients and caused significantly more mortality in HD patients than in PD patients. The proportion of deaths due to infection among dialysis patients has varied over time and decreased in recent years, going from more than 40% decades ago to about 15% more recently (24,25). The average proportion of deaths due to infection during the past 15 years was about 40% in our center, and has gradually decreased over time. During the past 5 years, the proportion of deaths due to infection among dialysis patients decreased to 15% – 30% in our center. The relative risk of infectious disease-related mortality did not differ significantly between dialysis patients overall, including nondiabetic and diabetic populations, after adjusting for independent risk factors in this study.

Whether PD patients had adverse cardiovascular outcomes due to possible metabolic side effects caused by long-term exposure to high glucose dialysate and chronic fluid overload is a concern. Previous studies by Locatelli et al. showed that no significant difference exists in cardiovascular mortality and de novo CVD overall, or for diabetic patients on PD and HD (26,27). When cardiovascular mortality was used as the primary end point in this study, PD patients had higher cardiovascular mortality than HD patients (Kaplan–Meier analysis, log-rank: 0.019). This difference in cardiovascular mortality was evident in the diabetic population after being stratified by diabetes mellitus (Kaplan–Meier analysis, log-rank: <0.001), and was not significant in the nondiabetic dialysis patients in this study. After adjusting for mortality risk using the Cox proportional model, PD modality had the same risk for cardiovascular mortality as HD in all dialysis patients; however, PD modality was still associated with a significantly higher relative risk of cardiovascular mortality than HD in the diabetic population (HD vs PD: HR 0.375, 95% CI 0.154 – 0.913). The putative difference of cardiovascular mortality risk was noted between diabetic PD and diabetic HD patients in this study.

The present study has several limitations. One major limitation is its small number of patients. The limit of small patient number, especially in subgroup analysis, obviously decreased the strength of the study results and could lead to controversial results when compared to larger registry-based studies. In addition, a strong association exists between lipid disturbance and CVD in dialysis patients (28). Increased serum cholesterol and triglyceride levels are common soon after PD is started (29). This study determined that PD patients had higher cholesterol and triglyceride levels than HD patients. To minimize the effect of this factor on cardiovascular mortality, this study adjusted for these two factors. Nevertheless, PD had a significant adverse impact on cardiovascular mortality. However, this study did not regularly measure the lipoprotein profile and apoprotein concentration. Altered low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, apolipoprotein A1, and apolipoprotein B may play roles in the high cardiovascular mortality in diabetic PD patients (30). Analyzing complete lipid profiles may be necessary in future investigations. New PD solutions containing glucose polymers or amino acid as osmotic agent, rather than glucose, are currently available (31,32). The cardiovascular risk for diabetic PD patients may be decreased by these new dialysates.

In conclusion, overall patient survival was similar between PD and HD patients. More large-series studies with sophisticated designs are needed to clarify the putative difference in cardiovascular mortality risk between diabetic patients on PD and diabetic patients on HD.


   DISCLOSURE
TOP
 ABSTRACT
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 DISCLOSURE
REFERENCES
 
The authors declare no financial conflict of interest exists.

Received 10 December 2007; accepted 4 July 2008.


   REFERENCES
TOP
 ABSTRACT
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 DISCLOSURE
 REFERENCES
 

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